MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Pain (1994); Seroma (2069); Hernia (2240)

Event Date 01/14/2014

Event Type  Injury  

Event Description

This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during the use of atrium medicals mesh product.It was alleged that a mesh was removed due to meshoma (mesh rolled up) and encapsulation.Since this is a potential legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, or sample was provided.The complaint alleges cultures taken at the time of removal show no evidence of infection.See scanned page.

Event Description

Plaintiff allegedly also experienced recurrence, pain, adhesions, debridement, incarcerated omentum, wound vac, fever, chills and bacteremia.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• MDR Report Key: 4768337
• MDR Text Key: 5789023
• Report Number: 1219977-2015-00136
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR